Evaluation of Seelens AF, an Aspheric Intra-ocular Lens | NCT00825747

Studies
Evaluation of Seelens AF, an Aspheric Intra-ocular Lens

NCT00825747

Sponsor

Hanita Lenses

Status

Withdrawn

Last Update Posted

Apr 13, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

SeeLens AF intra-ocular lens

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

study was closed

Expanded Access Info

Start Date

Jan 2009Actual

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jan 18, 2009

First Submission Date that Met QC Criteria

Jan 20, 2009

First Posted Date

Jan 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2021

Last Update Posted Date

Apr 13, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Senile cataract is managed by cataract extraction and intra-ocular lens (IOL) implantation. The purpose of this study is to evaluate the safety and efficacy of the SeeLens AF, an acrylic hydrophilic aspheric IOL. This lens was designed to reduce vision aberrations and secondary cataract formation rate.

Preoperative evaluation: Best corrected visual acuity, refraction, comprehensive slit lamp examination and biometry.

Surgical procedure: Cataract surgery using a clear corneal incision (1.8mm to2.4mm), phacoemulsification and implantation of the SeeLens AF to the capsular bag. IOL implantation parameters will be evaluated by the surgeon.

Postoperative follow up: Best corrected visual acuity, uncorrected visual acuity, refraction and comprehensive slit lamp examinations up to 3 months after surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SeeLens AF intra-ocular lens	Device	the SeeLens AF is an acrylic hydrophilic C shaped haptics intra-ocular lens, designed for implantation in the lenticular capsular bag or the sulcus during cataract surgery.		aspheric SeeLens

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best corrected visual acuity 3 months after SeeLens AF implantation		3 months

Secondary Outcomes

Measure	Description	Time Frame
Complications related to SeeLens AF implantation during cataract surgery.		3 months
Postoperative severe intra-ocular inflammation or infection		3 months
Prediction of ocular refraction after cataract surgery with Seelens AF implantation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Senile Cataract
Age >18 years
Cataract extraction using phacoemulsification
Corneal incision less than 1.5 mm

Exclusion Criteria:

Allergy/sensitivity to eye drops used during and after cataract surgery
Amblyopia/ strabismus
Ocular disease, other than cataract, diminishing visual acuity, such as corneal opacity, advanced glaucoma, diabetic retinopathy, exudative or moderate to severe non-exudative age-related macular degeneration, uveitis.
previous ocular surgery or ocular trauma in the investigated eye
Ocular anomaly, such as microphthalmos
Keratometry values less than 40 diopters or more than 47 diopters.
Ocular axial length less than 21.0 mm or longer than 25.0 mm
Intra-operative complications prior to intraocular lens implantation, such as tear of the posterior capsule.
posterior capsular scar
visual acuity in the fellow eye less than 20/200

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yokrat Ton, MD	Meir Medical Center, affiliated with Tel-Aviv University, Tel-Aviv, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka University Medical Center		Beersheba		84101	Israel
Meir Medical Center

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases